The FDA has approved a supplemental new drug application submitted by Otsuka Pharmaceutical and Bristol-Myers Squibb (BMS) for Abilify to treat manic and mixed episodes associated with bipolar I disorder in pediatric patients ages 10–17.

The Abilify (aripiprazole) approval is based on results from a 296-patient, four-week study that demonstrated the efficacy of the drug compared with placebo.

Patients were assigned randomly to receive Abilify 10- or 30-mg/day or placebo. Both Abilify doses demonstrated statistically significant improvement in symptoms, according to BMS.

The approval came less than a week after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the drug to treat moderate to severe manic episodes in bipolar I disorder.